Congress Reauthorizes FDA-Corrupting Prescription-Drug User Fees

On Sept. 30, 2022, Congress passed legislation that extended for five more years (until September 2027) the Food and Drug Administration’s (FDA’s) reliance on user fees paid by pharmaceutical companies[1] — which across all FDA user-fee programs totaled approximately $1.4 billion in fiscal year 2022 for review and oversight of prescription drugs.[2]

Drug manufacturers began paying user fees for the FDA’s review of their applications for approval of new prescription drugs after enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. With strong support from both industry and the FDA, these user fees have been reauthorized by Congress every five years since 1992 and have increased steadily.[3] For fiscal year 2023, the user fee paid by brand-name pharmaceutical companies for the initial review of a typical new drug application has been set at $3.2 million.[4]

PDUFA was intended to expedite the drug review process by providing the FDA with a new funding stream to hire additional medical experts and other staff to review new drug applications. In exchange for this industry funding, Congress required that the FDA meet benchmarks for timeliness of review and final decision-making for drug marketing applications.

In addition, each five-year reauthorization of PDUFA has provided an opportunity for drug companies and their well-paid advocates to lobby Congress for additional legislative provisions that have had nothing to do with the actual user fees but instead weakened the standards for approving new drugs. Remarkably, in contrast to all prior reauthorizations, no such provisions were attached to the 2022 PDUFA reauthorization legislation.

Importantly, the introduction of drug user fees gradually resulted in a fundamentally dangerous shift in the relationship between the FDA and the regulated pharmaceutical industry, such that the agency now views drug companies as partners rather than regulated entities. FDA leaders for several years now have been transparent about the agency’s partnership with industry. For example, in a 2014 speech to drug company executives, then-FDA Commissioner Margaret Hamburg touted a “new era of partnership” with the biopharmaceutical industry.[5]

Partnerships involve close cooperation between two or more entities seeking to advance shared interests and objectives. But the dynamics of a true partnership are incompatible with the relationship that should exist between a regulatory agency and regulated industry. The pharmaceutical industry’s primary interest is to maximize profits selling drugs, which can conflict with what should be the FDA’s primary interest: protecting public health.

Largely because of these user fees, the relationship between the FDA and the pharmaceutical industry over the past three decades has grown ever cozier — resulting in regulatory capture of the agency by Big Pharma. Reversing this regulatory capture will require Congress to rescind user-fee–based funding of the agency and restore public — not industry — funding of the agency.
 

References

[1] Food and Drug Administration. Prescription Drug User Fee Amendments. October 18, 2022. https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments. Accessed October 26, 2022.

[2] Department of Health and Human Services. Fiscal year 2023, Food and Drug Administration: Justification of estimates for appropriations committees. https://www.fda.gov/media/157192/download. Accessed October 26, 2022.

[3] Food and Drug Administration. Prescription Drug User Fee Amendments. October 18, 2022. https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments. Accessed October 26, 2022.

[4] Ibid.

[5] Weisman R. FDA chief urges ‘new era of partnership.’ April 5, 2014. The Boston Globe. http://www.bostonglobe.com/business/2014/04/04/fda-commissioner-calls-for-new-era-partnership-with-biopharma-industry/8676GZuMw8oEqaXt2HmkmK/story.html. Accessed October 26, 2022.